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A RCT Comparing Spontaneous Natural Cycles and Human Chorionic Gonadotrophin-induced Natural Cycles in FET

2015년 12월 10일 업데이트: The University of Hong Kong

A Randomized Controlled Comparison of Spontaneous Natural Cycles and Human Chorionic Gonadotrophin-induced Natural Cycles in Frozen-thawed Embryos Transfer

This is a randomized controlled trial on the comparison of the ongoing pregnancy rate in frozen-thawed embryo transfer cycles with spontaneous ovulation and hCG-induced natural cycles.

연구 개요

상세 설명

Embryo cryopreservation is essential nowadays. It allows the usage of surplus good quality embryos in frozen-thawed embryo transfer (FET) cycles which avoids embryo wastage and facilitates the adoption of transferring a small number of embryos in the fresh stimulation cycle so as to reduce the risk of multiple pregnancy during in vitro fertilization (IVF) treatment. Elective cryopreservation of all fresh embryos is also required in special circumstances where fresh transfer is undesirable, for example in cases where a high risk of ovarian hyperstimulation syndrome is anticipated. Fresh transfer is not advisable when serum progesterone level is elevated or hydrosalpinx is detected during ovarian stimulation.

The availability of FETs would increase the likelihood of successful pregnancy from a single superovulation and oocyte retrieval cycle. It has been estimated that in modern IVF programmes which incorporates embryo cryopreservation, up to 42% of all conceptions could be derived from FET (Borini et al, 2008).

Although the pregnancy rate in FET is comparable with stimulated IVF cycles, the optimal regimen to prepare the endometrium for implantation is not yet well proven. By a recent Cochrane review, there is no evidence to prove the use of one regimen in preference to another (Ghobara T 2008).

Natural cycles (NC) are considered the best regimen as it is physiological, where natural conception occurs in. However, there are two most commonly employed methods to time the ovulation in natural cycles. One is to use ultrasound (USG) to monitor the follicular growth and endometrial thickness, with the use of human chorionic gonadotrophin (hCG) to trigger ovulation in the presence of a dominant follicle around 17-18mm in diameter. Another is to monitor the blood hormonal concentration to detect the luteinising hormone (LH) surge associated with natural ovulation. There is scarce information in this area as only one randomized controlled trial compared these two approaches. The authors aimed to recruit 240 subjects, but the study was prematurely terminated as significant results were resulted in the first interim analysis when the sample size reached 124. The ongoing pregnancy rate was 31.1% in the group with spontaneous LH surge and 14.3% in the hCG-induced group (Fatemi et al., 2010).

The use of natural LH surge and hCG trigger in intrauterine insemination was compared too. A meta-analysis revealed a significantly higher clinical pregnancy rate in IUI cycles with natural LH surge than that with hCG trigger. However, the data from randomized controlled trial showed no significant difference. Also the data were contradictory when the analysis confined to a specific indication of subfertility (Kosmas et al., 2007). A cochrane review in 2012 also suggested there was no evidence to advise that any regimen was better than another (Cantineau et al., 2012).

This randomized controlled trial aims to compare the ongoing pregnancy rate of FET in spontaneous NC and hCG-induced NC. The hypothesis of this trial is that the ongoing pregnancy rate of FET is similar for spontaneous NC and hCG-induced NC. The advantage of hCG-induced NC is likely a reduction in the duration of monitoring for timing FET when compared with spontaneous NC.

연구 유형

중재적

등록 (실제)

300

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Guangzhou, 중국
        • Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University
      • Hong Kong, 홍콩, 852
        • Queen Mary Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  • Age of women <43 years
  • Regular menstrual cycles ranging from 21-35 days with not more than 4 days variation between cycles
  • Undergoing FET in natural cycles
  • Normal uterine cavity as shown on saline sonogram performed before the IVF cycle or normal uterine cavity shown on pelvic scanning during the stimulated IVF cycle
  • Endometrial thickness >=8mm in both stimulated IVF and FET cycles

Exclusion Criteria:

  • >3 previous IVF cycles
  • >6 embryos replaced without pregnancy
  • Irregular menstrual cycles
  • Subjects requiring clomid-induced cycles and hormonal replacement (HRT) cycles
  • History of previous FET cycles within the study period
  • Blastocyst transfer
  • Preimplantation genetic diagnosis treatment
  • Use of donor oocytes
  • Presence of hydrosalpinx not corrected surgically prior to FET
  • Recurrent miscarriage
  • Serum progesterone level on the day of LH surge or day of hCG >5 nmol/L or 1.5 pg/L (these patients will be retrospectively excluded)
  • Refusal to join the study

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Spontaneous NC
Timing by the onset of LH surge as shown daily blood monitoring of serum estradiol and LH levels
ultrasound scanning would be carried out from 18 days before the expected period to confirm follicular growth, followed by daily blood monitoring of serum E2 and LH levels when the dominant follicle reaches 13-14mm in diameter. Ultrasound scanning can be arranged accordingly if the leading follicle remains less than 10mm in diameter. 5 ml of blood would be taken daily. LH surge is defined as the LH level being double of the average of the previous three days and higher than 20 IU/L. Ultrasound examination will be performed on the next day after the LH surge to measure the endometrial thickness. The transfer will be scheduled three or four days after the LH surge (for cleavage stage embryos) or six days after LH surge (for blastocyst transfer).
실험적: hCG induced NC
Timing by giving hCG when the dominant follicle reaches >=17mm in diameter on ultrasound monitoring
ultrasound monitoring would be started from 18 days before the expected period to monitor follicular growth, followed by USG every 2-3 days. hCG, 5,000-10,000 IU will be given when the leading follicle is >/= 17 mm and the endometrium measures >/=8 mm. Serum E2, LH and progesterone levels will be measured on the day of hCG. Embryo transfer would be scheduled on the fourth or fifth days after hCG injection (for cleavage stage embryos) or seventh days (for blastocyst transfer).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
ongoing pregnancy rate
기간: 12 weeks after embryos transfer
the ongoing pregnancy rate which is defined as the number of viable pregnancies beyond 10-12 weeks gestation per transfer cycle
12 weeks after embryos transfer

2차 결과 측정

결과 측정
측정값 설명
기간
Days of monitoring for timing FET
기간: 4 weeks after last menstrual period
The number of days needed for the monitoring for the timing of FET
4 weeks after last menstrual period
Endometrial thickness on day of hCG or the next day after LH surge
기간: 2-3 weeks after LMP
The measurement of the endometrial thickness on the day of hCG or the next day after LH surge
2-3 weeks after LMP
Implantation rate
기간: 4-6 weeks after embryo transfer
Implantation rate: number of gestational sacs per number of embryos transferred
4-6 weeks after embryo transfer
pregnancy rate
기간: 2-4 weeks after embryo transfer
number of positive pregnancy rate per transfer
2-4 weeks after embryo transfer
Clinical pregnancy rate
기간: 6-8 weeks after embryo transfer
Number of pregnancy with positive fetal pulsation on scanning at 6 weeks of gestation.
6-8 weeks after embryo transfer
Miscarriage rate
기간: 20 weeks after embryo transfer
rate of pregnancy loss <20 weeks per transfer cycles
20 weeks after embryo transfer
Multiple pregnancy rate
기간: 20 weeks after embryo transfer
The rate of multiple pregnancy after ET
20 weeks after embryo transfer

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 10월 1일

기본 완료 (실제)

2015년 12월 1일

연구 완료 (실제)

2015년 12월 1일

연구 등록 날짜

최초 제출

2014년 7월 20일

QC 기준을 충족하는 최초 제출

2014년 7월 21일

처음 게시됨 (추정)

2014년 7월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 12월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 12월 10일

마지막으로 확인됨

2015년 12월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HKU-VL-NChCGFET

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